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Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Non Recruiting
18 years and older
All
Phase 4

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Overview

This clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (AF). Atrial fibrillation is an abnormal heart rhythm which research has shown is related in part to obesity and diabetes.

It is anticipated that the participants treated in the metformin arm will have greater freedom from recurrent atrial arrhythmias after ablation.

Eligible participants enrolled in the trial will be assigned to one of the treatment arms (no treatment or metformin) and have follow-up visits up to approximately 1 year after the ablation. Additionally, all patients will also receive education on lifestyle changes and exercise which are standard of care.

Eligibility

Inclusion Criteria:

  • Body Mass Index (BMI) >25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation
  • All subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Individuals who are already taking metformin or other antidiabetic medications, including insulin
  • Known diabetes
  • Known allergy or Food and Drug Administration (FDA)-labeled contraindication to taking metformin (estimated glomerular filtration rate (eGFR)<30 millilitres per minute (mL/min)/1.73 square meters (m2), hypersensitivity to metformin, acute or chronic metabolic acidosis)
  • Patients taking carbonic anhydrase inhibitors
  • eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease
  • Acute or chronic metabolic acidosis (serum bicarbonate <22 milliequivalents per liter (mEq/L))
  • History of significant alcohol use (>2 drinks/day on average)
  • History of hepatic dysfunction (serum bilirubin 1.5 times greater than ULN)
  • History of New York Heart Association (NYHA) Class III or IV heart failure
  • Pregnancy or nursing

Study details
    Atrial Fibrillation

NCT04625946

University of Michigan

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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